Stanford IRB • SCRO • APLAC
IRB • SCRO Institutional Review Board IRB • SCRO • APLAC
IRB • SCRO • APLAC

Consent Waivers & Alterations

For certain types of research, obtaining signed consent may not be required. The IRB may grant a waiver or alteration of the informed consent process, or a waiver of documentation of consent (waiver of signature) when certain conditions are met.

obtaining informed consent

Waiver/Alteration of Consent

Federal regulations under 45 CFR 46.116 and 21 CFR 50.22 permit the IRB to grant a waiver/alteration of consent if the following criteria are met:

  • The research involves no more than minimal risk;
  • The research could not practicably be carried out without the waiver or alteration;
  • If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
  • The waiver or alteration will not adversely affect the rights and welfare of the participants; and
  • Whenever appropriate, the participants or legally authorized representatives will be provided with additional pertinent information after participation.

See the infographics below on How to Justify Waiving Informed Consent and How to Justify Altering Informed Consent.

Waiver of Documentation of Consent

Federal regulations under 45 CFR 46.117 and 21 CFR 56.109 permit the IRB to grant a waiver/alteration of consent if the following criteria are met:

  • The only record linking the participants and the research would be the consent form and the principal risk would be potential harm resulting from a breach of confidentiality;
  • The research presents no more than minimal risk to participants and involves no procedures for which written consent is normally required outside of the research context; or
  • The participants or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects, and provided there is an appropriate mechanism for documenting that informed consent was obtained.

See the infographic below on How to Justify Informed Consent without Signatures.

Consent Waiver/Alteration FAQs

When research involves deception, it may be necessary to include only certain information in the consent form in order to conduct the study. For example, if the full study purpose was made known to participants, then the study would not be practicable to conduct (e.g. research on risk analysis or economics-based decision making). In such research, the IRB may be able to approve an Alteration of Consent to allow certain required (basic) consent elements to be omitted from the consent form. In certain cases, a debrief with the participant after completion of the research may be appropriate.

The IRB will review the request for a waiver/alteration in the context of the study to determine if the regulatory requirements allowing for the waiver/alteration are met. In general, if signed consent can feasibly be obtained from the participant or their legally authorized representative, a waiver or alteration may not be appropriate.

See information on Parental Permission (Consent) Requirements in School-Based Research.